Quality-Regulatory Specialist (Complaints) Job in Toronto/Gta, Ontario Canada
This position will be responsible for key company quality activities such as customer feedback management, complaint handling and product incident report review.
This headcount will also provide back-up for critical regulatory compliance processes including adverse event reporting and recalls.
3. Key Responsibilities/Duties: In order of importance, describe the most important areas of accountability of this job. What needs to be done to achieve what end results, within what framework and timeframe?
a) Manage the Philips customer feedback process for Canada and the complaint handling process in accordance with Health Canada requirements. Maintain and update regulatory files with appropriate information (e.g. investigations, follow-up, customer communications, closure, etc).
b) Review product incident (adverse event) reports before they are submitted to Health Canada within 10 days of death or serious injury, within 30 days of potential for death or serious injury or within 48 hours for foreign incidents related to corrective actions. Track actions related to product incidents and ensure closure by the due dates identified to Health Canada.
c) Participate in the coordination of external government audits and Philips Global quality audits
d) Publish regular reports of quality management system metrics for customer feedback and problem reporting.
e) Provide back-up for critical regulatory compliance processes including adverse event reporting and recalls.
Post-secondary degree in a Life Science field (chemistry, biology, physiology, psychology etc.) or equivalent
3-5 years experience in a quality position working with ISO quality standards or GMP requirements for a medical device or pharmaceutical company
Internal auditor training and experience
Excellent organizational skills with an attention to detail and follow-through
Aptitude for PC software programs (i.e. MS Office)
Superior problem-solving and trouble-shooting skills.
Professional written and verbal communication skills
Strong teamwork skills
Ability to work under a minimum of supervision
Philips is an Equal Opportunity Employer
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